Trials / Not Yet Recruiting
Not Yet RecruitingNCT07049653
Anifrolumab Pregnancy Study
A Non-Interventional Multi-Database Post-Authorisation Study to Assess Pregnancy-Related Safety Data From Women With SLE Exposed to Anifrolumab
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 627 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- Female
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
Summary
This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.
Detailed description
The aim of this study is to describe congenital malformations, adverse pregnancy and birth outcomes in pregnancies/offspring from women with moderate/severe SLE exposed to anifrolumab during pregnancy and to compare with outcomes in women with moderate/severe SLE who are exposed to other standard of care but not anifrolumab. Adverse outcomes related to infant growth up to one year of age will also be investigated.
Conditions
Timeline
- Start date
- 2026-01-31
- Primary completion
- 2030-12-10
- Completion
- 2030-12-10
- First posted
- 2025-07-03
- Last updated
- 2025-08-15
Source: ClinicalTrials.gov record NCT07049653. Inclusion in this directory is not an endorsement.